Quality System Specialist
Job Summary
Detail-oriented and collaborative, the full-time temporary Life Sciences Quality System Specialist will support critical IVDR documentation remediation and migration efforts, ensuring compliance with regulatory and quality system requirements while working remotely.
Key responsibilities
- Support completion of IVDR documentation remediation activities for legacy products
- Review, consolidate, and reconcile Design History Files (DHF) and related documentation
- Coordinate with subject matter experts to identify and clarify documentation gaps
Required qualifications
- Bachelor's degree in Life Sciences, Engineering, Quality, Regulatory Affairs, or a related technical discipline; equivalent experience will be considered
- 5+ years of experience in a regulated quality, design control, or product development environment
- Working knowledge of ISO 13485, ISO 9001, FDA 21 CFR 820/QMSR, or similar quality system requirements
- Experience with reviewing and reconciling technical documentation
- Proficiency with Microsoft Office applications; experience with Veeva, EtQ, SAP, or Salesforce is preferred
Complete Job Description
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